Publication | Closed Access
International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group.
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PharmacotherapyUniform DefinitionsAdverse Drug ReactionDrug HypersensitivityTranslational MedicineInternational ReportingMultinational Pharmaceutical ManufacturersAdverse EventToxicologyPublic HealthDrug ToxicityDrug SafetySingle Reporting FormOutcomes ResearchPharmacologyEpidemiologyEmergency MedicineCioms ProjectAdverse Drug ReactionsPatient SafetyInternational HealthDrug TrialMedicinePharmacoepidemiology
A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.